Director, Regulatory Operations

Pharvaris is a Nasdaq listed late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple areas of the body including the airway, which can be life-threatening. We have a culture built on the core values of considering others carefully, leading with trust, ensuring rigor and diversity of thought, and contributing freely. Our company is driven by individuals committed to developing breakthrough therapies which can have a real impact on people’s lives. If you are looking for a place where your work can have meaning and you can make a difference – Pharvaris is the place for you!

We are now looking to add capabilities in the Regulatory function and seeking to therefore hire a Director, Regulatory Operations, to join our Regulatory Affairs team and report to our Vice President, Head of Regulatory Affairs & Quality.

The Director, Regulatory Operations will lead global regulatory operations, overseeing the submission process for regulatory filings and ensuring compliance with regulatory requirements. This role will provide operational oversight and support in the preparation and implementation of the regulatory strategic and operational plans. This role will be responsible for the launch and maintenance of RegDocs Connect RIM (Regulatory Information Management) system. The successful candidate will have a background in non-Veeva RIM systems, as well as experience in filing NDAs and MAAs with an external publishing vendor.

Location

This role is preferably based in The United States (Remote: Preference East Coast). At Pharvaris, we promote and enable a flexible hybrid work-environment and support our talents to be home based and work virtually.

Responsibilities

• Provide regulatory operations expertise and leadership to cross functional teams supporting the pipeline, train and lead regulatory operations personnel reporting into this role.
• Lead the development, refinement, and implementation of internal processes, procedures, work instructions and training programs for submission production and operational support activities. As needed, train colleagues and project teams.
• Oversee full implementation, maintenance & optimization of a RegDocs Connect RIM system.
• Provide RIM system leadership by overseeing the development of RIM projects based on current and future business needs optimizing use of system attributes
• Oversee and manage all Regulatory Operations global submissions, systems related projects and submission compliance.
• Oversee management of external publishing vendor.
• Ensure proper maintenance of regulatory submissions filing, Health Authority correspondence logs, and archival of previous regulatory submissions.
• Oversee build of submission binders & content plans for future regulatory submissions globally.
• Stay current with regulatory requirements and industry best practices.
• Prepare and present regulatory reports, metrics, and dashboards.
• Lead budgeting and forecasting activities for the Global Regulatory Operations function including managing vendors.
• Proactively identify process improvement opportunities which align with business needs, and propose and deploy solutions as needed.

Requirements

• Bachelor’s Degree in life sciences or related field is strongly preferred.
• 10+ years of work experience in pharmaceutical/biotech regulatory affairs, with at least 8 years of Regulatory Operations experience.
• NDA/MAA filing experience.
• Expert knowledge of regulatory submission publishing standards and procedures, including computer word processing and electronic document management systems
• Understanding of drug development and business processes.
• Knowledge and experience of eCTD submissions.
• Knowledge of FDA, EMA, and ICH guidelines.
• Proven internal and external leadership with ability to work cross-functionally and globally.
• Possess strong communication and interpersonal skills with excellent attention to detail.
• Ability to work independently and successfully in a matrix environment, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Ability to foster effective relationships and collaboration, motivate others, influence without authority via proven project management and time management skills.
• Extensive knowledge in the implementation of GxP Systems (e.g. Document Management Systems) and formatting solutions (e.g. authoring templates)]
• Clear understanding of the role that Regulatory Systems and user adoption plays in creating Regulatory efficiencies .Comfortable in a small company environment that is fast paced, challenging and where all senior staff must take on a hands-on approach to get results.
• Comfortable in a small company environment that is fast paced, challenging and where all senior staff must take on a hands-on approach to get results.